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Pfizer Plans R&D, Manufacturing Expansion In Asia

In another indication of big pharma's expanding interest in Asia, Pfizer announced Nov. 30 that it will seek to increase the amount of R&D and manufacturing it does in that part of the world.

FDA Says Lack of Resources and Staff Hinder Its Foreign Inspections

Lack of resources and staff are two of the main reasons why FDA does not conduct more overseas pre-approval and post-market inspections, Deborah Autor, director of FDA’s Center for Drug Evaluation’s Office of Compliance, told generic drug makers meeting in Bethesda, Md.

Gilead Expands Hep C Portfolio With LG Life Sciences Deal

Gilead Sciences is gaining a Phase II pan-caspase inhibitor for hepatitis C through a licensing agreement with LG Life Sciences worth up to $202 million announced Nov. 7.

Artisan, Singapore's A-Bio Join Forces On Recombinant Sepsis Candidate

Artisan Pharma and Singapore-based A-Bio Pharma have established a relationship under which the Asian firm will provide process development, scale-up and manufacturing support for Artisan's investigational recombinant protein ART-123, the firms announced Sept. 17.

Nexavar Survival Study In Asia-Pacific Patients With Liver Cancer Halted Early

Bayer and Onyx Pharmaceuticals announced Aug. 27 that a trial evaluating Nexavar (sorafenib) in Asia-Pacific patients with hepatocellular carcinoma will be stopped early to allow all patients to receive the drug based on positive study results and the recommendation of an independent data monitoring committee.

Ex-FDA Commissioner Crawford Calls For New Global Harmonization Effort

CAMBRIDGE, MA-A new global organization should be established to promote the harmonization of regulatory requirements between countries, Lester Crawford proposed Aug. 22 at the FDA Regulatory and Compliance Symposium.

Merck Opens Asia Pacific Headquarters In Singapore

Merck has opened an Asia Pacific headquarters in Singapore, the firm announced Aug. 21.

Novartis Withdraws Prexige In Australia Ahead Of FDA Decision Due To Deaths

A decision to withdraw Novartis' Prexige (lumiracoxib) in Australia after two patients died from serious liver injury following treatment with the drug is likely to impact the outcome of FDA's decision on a pending NDA for the COX-2 inhibitor.

Pacific Beach BioSciences Licenses Novel Fluoroquinolone From Korean Firm Dong Wha

Pacific Beach BioSciences, a San Diego start-up, and Dong Wha Pharmaceutical have signed a development and commercialization deal for zabofloxacin, a novel fluoroquinolone antibiotic discovered by the Korean pharma, the companies announced Aug. 10.